Evaluation of the AccessPath™ Transseptal Introducer Sheath used in Patients undergoing catheter ablation to treat Atrial Fibrillatio
- Conditions
- Atrial FibrillationCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12619000376145
- Lead Sponsor
- CardioPathways, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
suitable candidate scheduled for percutaneous transseptal access for atrial fibrillation ablation procedures
Eighteen to eighty years of age
Signed informed consent
1. Intracardiac thrombus, tumor or other abnormality that precludes
catheter introduction and placement
2.Severe cerebrovascular disease or history of cerebrovascular event
within one (1) month
3. Patients with severely impaired kidney function as measured by a
creatinine of > 150 ml/min.
4. Active gastrointestinal bleeding, infection or fever (> 100.5/38C)
5. Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
6. Structural heart disease of clinical significance including:
a. Stable/unstable angina or ongoing myocardial ischemia
b. Myocardial infarction (MI) within three months of enrollment
c. Aortic or mitral valve disease > Grade II
d. Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
7. Female patient is pregnant or lactating
8. Untreatable allergy to contrast media
9. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
10. History of blood clotting (bleeding or thrombotic) abnormalities
11. Known sensitivities to heparin or warfarin
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method